Valved male luer with vacuum feature

ABSTRACT

A male luer connector device that attaches to any standard female luer valve to open a flow channel between the two luers. The male luer is comprised of a tubular housing element, a resilient member contained within the housing and extending within an inner tubular portion defined in the housing, a resilient member that extends within the inner tubular portion of the housing, and a valve member attached to the resilient member that seals the tubular portion. When the male luer is engaged with any standard female luer, a female luer connector device drives the resilient member of the male luer into a compressed position to open the forward end of the male luer and permit liquid flow between the luers.

BACKGROUND OF THE INVENTION

This invention relates to an improved male luer connector device thatattaches to a female luer valve to open a flow channel through the maleluer. Once the engagement of the luers has been established, thesevalves are used to make connections in hospitals for intravenous (IV)devices in order to be used in medical liquid flow applications.

Luer devices are used in particular in a variety of medical applicationswhere there is a desire to interconnect together male and femaleconnector parts onto tubing material that is connected to an IV. Themost common types of IV fluid exchanges use a syringe fitted with anozzle that is designed to be received into a corresponding receiverattached to the IV device. The receiver often has a hollow tubularcannula or post that routes fluid into a line inserted into the IVextending into the patient's veins.

Typical luer connections utilize a male luer connector that is insertedinto a female luer connector. The male luer connector is threaded ontocorresponding threads of the female luer connector to engage the two sothat fluid may be passed between them without escaping or leaking fromthe connection. Because these connections are subject to coming loose ordisengaging, there is always a possibility that fluid being passedwithin these tubes can escape. When using hazardous drugs, such as thoseused for chemotherapy treatments, the possibility of escaping fluids canbe a dangerous problem. Additionally, even if the fluid does not leakwhen the connectors are engaged, once they are disengaged, the residualamount of fluid remaining on the tip of the connectors can still beharmful. While this amount may be less than an amount escaping from theconnectors, it can still be significant enough to cause harm to anyperson exposed.

Therefore, there is a need for a luer connection that securely containsthe fluid materials included therein when luers are engaged to oneanother. There is also a need for a luer connection that seals off themale luer connector in a male-female connection so that users of theconnector are protected from hazardous drugs that remain on the luer tipsurface when disengaged.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a new and improvedmale luer connector device for engagement with a female luer valve forconnection to an IV or other fluid-type connections.

According to one aspect of the present invention, a male luer connectordevice is provided for establishing a connection with a correspondingcore rod type female luer valve. The device comprises a housing, aninner chamber, a resilient member, and a valve member. The housing hasan outer tubular portion and an inner tubular portion and first andsecond necked areas and the valve member has a tip that seals theforward end of the inner tubular portion. The resilient member can beelastically displaced and extends within the inner tubular portion ofthe housing.

The male luer is inserted into a corresponding core rod or cannulafemale luer and the two are engaged. When the female luer engages withthe male luer, the core rod within the female luer valve pushes firstagainst the tip of the male luer. The tip then moves and collapses thevalve member at the first necked area. Further engagement continues tomove the valve member and then collapses the resilient member at thesecond necked area. Once the luers are entirely in the engaged position,fluid may flow between the luers and enter or exit the female luer viaan inlet port. If it is desired, the male luer valve does not have to becontained within a housing element. Instead, it may be self contained oradditionally, those skilled in the art will recognize that the male luervalve can be contained within other enclosures.

According to another aspect of the present invention, a male luerconnector device is provided that comprises a resilient member, a innerchamber, and a valve member. This embodiment functions identically tothe prior embodiment with the exception that the valve member is eitherintegrally formed with the resilient member or can be abutting theresilient member. The resilient member can be formed of an elastomericmaterial or can be a spring formed of many different materials. Theinner chamber is then sealed off by the integrally formed member. Whenan appropriate female luer valve is engaged with the male luer, theintegrally formed member collapses in order to permit liquid flowbetween the two luers. If desired, this embodiment may alternativelycontain a housing.

In a further embodiment, a male luer is described that can work with afemale luer that does not contain a cannula or post. This luer comprisesa housing, a first tubular member, a resilient member, a valve member,and a slidable sleeve member. The housing has an outer tubular wall anda first tubular member which extends co-axially within the housing. Thefirst tubular member has at least one axially extending slot and aforward end having a valve seat. The valve member is located at the endof the resilient member for sealing engagement of the valve seat. Theresilient member has at least one guide portion that extends radiallyoutwardly through the axial slot. The sleeve member is slidably mountedover the first tubular member and the outer tubular wall so that thesleeve traps the guide portion. When the female luer is engaged to themale luer, the housing of the female luer engages the sleeve and slidesit rearwardly into the male luer housing. This pushes the resilientmember and the valve member rearwardly into a retracted position toallow liquid flow between the two luers. Once again in this embodiment,the housing element does not have to be present. Instead, the male luervalve may be self contained or contained within other types ofenclosures.

The configurations of the present invention described herein areadvantageous for many reasons. When the male luer is mated or disengagedwith an appropriate female luer valve, the male connector seals off toprotect any user from exposure to potentially hazardous fluids. Thevalve contained on the end of the male luer is self-closing so that itensures that minimal amounts of fluid remain on any exposed surface ofthe luer. This advantage helps ensure hazardous drugs, such as thoseused in chemotherapy treatments, do not remain on the luer. Also, bodilyfluids, such as blood, do not remain on the luer in order to minimizeexposure to potentially diseased blood. The valve design allows eithermutual swabbing or one-sided swabbing because there are minimal creviceson the luer and the tip member is substantially flush. Additionally, inone embodiment, the configuration of the male luer provides anotheradvantage in that it creates a vacuum effect on the tip of the luer whenthe male and female luer are disengaged. This vacuum tip feature acts tominimize residual fluid on any surface and therefore minimizes all typesof exposure.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood from the followingdetailed description of an exemplary embodiment of the invention, takenin conjunction with the accompanying drawings in which like referencenumerals refer to like parts and in which:

FIG. 1 is a side view of the two components of the male to female luerconnection of the luer fitting;

FIG. 2 is an enlarged sectional view taken on line 2-2 of FIG. 1;

FIG. 3 is a view similar to FIG. 2, with the components partiallyengaged;

FIG. 4 is a view similar to FIG. 3, with the components fully engaged;

FIG. 5 is a view similar to a portion of FIG. 2, showing an alternativeintegrated spring member;

FIG. 6 is a view similar to FIG. 5, showing an alternative single stagevalve;

FIG. 7 is a view similar to FIG. 6, showing the valve opened;

FIG. 8 is a view similar to FIG. 5, showing a ball type valve;

FIG. 9 is a sectional view showing an alternative slide actuated valve;

FIG. 10 is a view similar to FIG. 9, showing the valve opened;

FIG. 11 is a view similar to FIG. 9, showing an alternative slideactuated valve;

FIG. 12 is a view similar to FIG. 10, showing an alternative valve foruse with a female luer valve that does not have a cannula or post; and

FIG. 13 is an illustration of a male luer valve that does not contain ahousing element.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the two components of the male to female luerconnection of the luer fitting. The fitting is comprised of a male luer10 that is intended to engage with a female luer that has an existingflush top female luer valve. The female luer 24 is not limited to aparticular type but an exemplar luer is illustrated here. The femaleluer illustrated here is one where the valve shuts off. This female luer24 contains a housing element 28 with a cannula or post 26. On the outersurface of the forward end of the housing 28 there are threads 30 thatpermit engagement of the female luer 24 with the male luer 10. In thisembodiment the male luer 10 is comprised of a housing element 12. Theinner wall of the housing 12 contains threads 32 that engage thecomplimentary threads 30 of the female luer connector. Housing 12 has aninner tubular portion 16 of reduced diameter that projects forwardlythat has a first necked area 36 and a second necked area 38 (See FIG.2). The inner tubular portion defines an internal chamber 13 with aforward opening 33 (See FIG. 2). A valve member 18 is biased into anextended position sealing opening 33 by resilient member or spring 14.Spring 14 acts between distal end of chamber 13 and valve member 18.Valve member 18 includes a resilient portion 20 and a forward tip member22. FIG. 1 illustrates the two luers 10, 24 in the unengaged position.Other types of female luer valves that do not contain a cannula or post.By way of example, U.S. Pat. No. 5,676,346 by Leinsing and U.S. Pat. No.5,782,816 by Werschmidt illustrate these types of luer valves.

FIGS. 2 to 5 illustrate the male luer 1 0 and the female luer 24 as theybecome engaged with one another. FIG. 2 illustrates the two luers 10, 24when they are completely unengaged. The cannula or post 26 may have anopening 40 for entrance and exit of fluid between the two luers. Otherduct systems (not shown) are possible and may be used. The cannula orpost 26 is mounted in a chamber within a sleeve 34. This sleeve 34 canbe made of rubber or any other suitable resilient material and serves asa valve member stopper. Sleeve 34 has a forward end opening 35 which issealed shut in the unengaged position of FIG. 2. The male luer has aforward end that has a first necked area 36 and a second necked area 38spaced rearwardly from the first necked area 36. FIG. 3 illustrates themale luer 10 beginning to be inserted into the female luer 24. Once thethreads 30,32 begin to engage, the forward end 33 of housing 12 pushesthe sleeve 34 back until the opening 35 is forced to open over the endof the cannula 26. The cannula or post 26 then comes into contact withthe tip of valve member 18 and begins to push it rearwardly so that thecannula or post 26 displaces the valve element front section 22. Thismovement begins to separate the seal surface of the first necked area 36from its seat. As the tip member 22 begins to be pushed back, the secondresilient portion 20 is collapsed, compressing the valve element cavity19. This unseals the first necked area 36 and displaces the liquidcontained within the cavity 19. This displaced liquid flows temporarilyinto the female luer valve 24. As this pressure is applied, the valvemember is compressed and pushed further inwardly into chamber 13.

FIG. 4 illustrates the positioning of the luer members when the female24 and male 10 luers have been even further engaged. The cannula or post26 begins to push even more onto the tip member 22 and collapse thefirst resilient member 14 so that the second necked area 38 is unsealed.At this point, more liquid is displaced by the further insertion of thecannula or post into the vacuum section 21 of the male luer as indicatedby the arrows in FIG. 4. The opening 40 on the cannula or post 26permits fluid to pass into and out of the female luer 24. This displacedliquid creates the volume which will be refilled when the action isreversed.

Upon disconnection of the male luer 10 valve from the female luer valve24, the volume of liquid that was displaced during the connection of thetwo valves is restored to the original positions, thus creating arelative vacuum. When the female luer 24 is removed from the male luer10, the main seal created by the second necked area 38 makes contactwith its seat. This isolates the vacuum section 21 from the upstreamliquid. As the cannula or post 26 is withdrawn, cavity 19 is restored asresilient portion 20 resiles to its uncollapsed natural shape. As thisrestoration occurs, liquid is drawn into cavity 19. Because the secondnecked area 38 is closed, this liquid will be drawn from the interfacebetween the male luer 10 and the female luer 24. This effect is enhancedby the volume represented by the cannula or post 26, which must bereplaced as the cannula or post 26 is withdrawn. The relative vacuumcreated will attempt to draw liquid into the vacuum section until theseal surface of the first necked area 36 again contacts its seat.

FIG. 5 illustrates the same type of dual stage valve as above only thatit is formed with the spring 14 integrally connected to the valve member42. The housing 12 contains the inner sleeve 16 and positioned inside ofthe inner sleeve 16 is an inner chamber 13. The function of thisembodiment is the same as the previously described embodiments with theexception that the spring 14 can be comprised of elastomeric or othertypes of material that are integrally connected with the valve member42.

FIGS. 6 and 7 illustrate a male luer according to another embodiment ofthe present invention. This apparatus is a single stage luer valve withan integral resilient member. In this embodiment, the male luer has ahousing 12 with threads 32 on the inner wall of the housing forengagement to the complimentary threads on the female luer 30. The innerchamber 13 is sealed by a valve member 42 that is integrally formed withthe resilient member and the tip. This new valve member 42 thereforefunctions as in the previous embodiment except that all members areformed in one piece, rather than including a separate resilient member.This embodiment demonstrates a single stage luer valve in that once thefemale luer engages with the valve member 42, the member 42 moves as asingle piece rather than as several different pieces as described above.FIG. 7 illustrates the luer of FIG. 6 engaged with a female luer 24 andpermitting fluid flow. Once the two luers 10, 24 are engaged, thecannula or post 26 of the female luer 24 collapses the valve member 42and permits fluid flow via the opening 40 in the cannula or post 26 andalso via an opening 44 in the rear end of the valve member 42.

FIG. 8 illustrates another embodiment of the present invention. In thisembodiment, the housing 12 of the male luer is similar to the previousembodiments. Additionally, contained within the inner sleeve 16 is aresilient member or spring 14. However, in this embodiment, the valvecontained on the end of the resilient member is shown as a ball 46. Thisball may be made of various types of materials as for example,elastomeric material. Additionally, the forward end opening of chamber13 is exemplefied as a part-spherical seat 47 to accommodate for ballvalve 46. Those skilled in the art will recognize that the valvecontained on the end of the resilient member or spring 14 can be of avariety of shapes. However, the shape of the tip of the male luer 10needs to be one that corresponds to the shape of the tip of the femaleluer 24.

FIGS. 9 and 10 illustrate a modified connector according to yet anotherembodiment of the present invention, in which a modified male luer 50 isreleasably securable to the female luer 24 of the previous embodiments.Male luer 50 comprises a housing with a cylindrical outer wall 52 and aninner tubular support 54 which projects into the cylindrical housingfrom rear end 53 and extends along part of the length of the housing.Outer wall 52 has internal threads 32 for engaging the female luerthreads 30 and a larger diameter than the inner support 54 which extendsfrom the rear end 53 of the housing and projects out of the forward endof the housing. A resilient sleeve or bladder member 56 is securedbetween the tubular member 55 and support 54 at its rear end, andprojects forwardly within tubular member 55 to its forward end opening57. Bladder member 56 has a forward end opening 58 which is sealed shutby the inwardly tapered end portion of the tubular member 55 when in theextended, unconnected position of FIG. 9. The forward end portion 58 ofbladder member 56 acts as a valve to seal the end opening 57 of the maleluer in the position illustrated in FIG. 9.

Tubular member 55 of the male luer is of smaller diameter than the innercylindrical wall 52 of the housing, to leave an annular gap between themember 55 and inner wall 52. A sliding sleeve 60 is slidably mountedover the tubular member 55 in this annular gap. Sleeve 60 hasdiametrically opposed openings 62, and the tubular member 55 hasopposing elongate, axially extending slots 64. Oppositely directed wingsor guide portions 65 on the inner bladder or sleeve member 56 projectradially outwardly through the slots 64 and into the openings 62. Thus,when the sleeve is in the fully extended position of FIG. 9, it willpull the sliding sleeve forwardly into the illustrated position. Thecorrugated portion 66 of bladder member 56 acts as a spring to bias theforward end of the bladder member 56 and the sliding sleeve 60 into theextended position.

FIG. 10 illustrates a female luer 24 connected to male luer 50. As theforward end of the female luer housing is threaded into the cylindricalwall of the male housing, it will engage the forward end 67 of thesliding sleeve 60, urging the sleeve, and thus the bladder member 56,rearwardly and moving the forward end portion of the bladder member outof sealing engagement with the forward end opening of tubular member 55.This permits the forward end opening 58 to spring open, as indicated. Atthe same time, the forward end of tubular member 55 will force thesleeve 34 in the female luer rearwardly so that it passes over the endof cannula 26, which then extends into the open forward end of thetubular member. This allows fluid flow through the two luers, via theinner tubular support, open end 58 of the bladder member 56, and theopenings 40 in the cannula 26. When the luers are disconnected, thecompressed corrugated portion 66 of the bladder member 56 urges theforward end portion to move back into sealing engagement with theforward end of the tubular member 55, preventing any fluid leakage.

FIG. 11 is a view similar to FIG. 9, showing an alternative slideactuated valve except that the resilient sleeve or bladder member 56does not have a corrugated portion and instead has a separate springmember 68. The spring member 68 can any type as for example, those madeof metal or elastomeric material. The function of the male luer valve isthe same, it is merely the spring member 68 that replaces the previouscorrugated member.

FIG. 12 is a view similar to FIG. 1 0, showing an alternative valve foruse with a female luer valve that does not have a cannula or post. Theouter surface of the forward end of the housing 28 engages andcompresses the forward end 67 of the sliding sleeve 60 of the male luervalve. As the forward end of the female luer valve housing 28 continuesto further displace the sliding sleeve 60, the bladder member 56,continues to move rearwardly and moves the forward end portion of thebladder member out of sealing engagement with the forward end opening ofthe tubular member 55. This permits the forward end opening 58 to springopen. This allows fluid flow through the two luers, via the innertubular support, open end 58 of the bladder member 56. Once the luersare disconnected, the sealing engagement as previously described onceagain occurs.

FIG. 13 is an illustration of a male luer valve that does not contain ahousing element. This view is similar to FIG. 2 except that the maleluer valve is not contained within a housing element and instead can beself-sustained. However, the function of the male luer valve is the sameas that explained for FIG. 2 only that the engagement with the femaleluer housing does not occur with the male luer housing.

The various embodiments of the male luer described above provide forautomatic sealing of the end opening in the male luer as the male andfemale luers are disconnected, reducing the risk of an operator cominginto contact with the potentially hazardous fluid flowing through theconnector.

Although some exemplary embodiments of the invention have been describedabove by way of example only, it will be understood by those skilled inthe field that modifications may be made to the disclosed embodimentswithout departing from the scope of the invention, which is defined bythe appended claims.

1-32. (canceled)
 33. A male medical fluid connector for engaging afemale connector to open a flow channel through the male connector, themale connector comprising: a tubular portion having a forward end forengaging a female connector; a valve member located within the tubularportion, the valve member having an open position when the tubularportion is engaged with a female connector at which position fluid canflow through the tubular portion, and a closed position when the tubularportion is disengaged from a female connector at which position fluid isprevented from flowing through the tubular portion; and means forcreating a relative vacuum within the forward end of the tubularportion.
 34. The male medical fluid connector of claim 33 furthercomprising means for drawing liquid into the forward end of the tubularmember upon disconnection of the male connector from the femaleconnector.
 35. The male medical fluid connector of claim 34 wherein thedrawing means comprises the valve member which is located within thetubular portion so as to isolate the vacuum means from upstream liquidupon disconnection of the male connector from the female connector. 36.The male medical fluid connector of claim 35 wherein: the valve membercomprises a dual stage valve; the vacuum means is located between firstand second valve stages of the dual stage valve; the first valve stageis located so as to isolate the vacuum means from upstream liquid; thevacuum means is configured such that after the first valve stage closes,the vacuum means creates the relative vacuum thus drawing liquid thatmay exist on the forward end into the forward end of the tubular memberbefore the second valve stage closes; and the second valve stage islocated at the forward end.
 37. The male medical fluid connector ofclaim 33 wherein the vacuum means comprises a compressible cavity formedin the valve member, the cavity being compressed when the valve memberis in the open position and the cavity being restored when the valveelement is in the closed position.
 38. The male medical fluid connectorof claim 33 further comprising a resilient member that biases the valvemember to the closed position.
 39. The male medical fluid connector ofclaim 33 wherein the vacuum means comprises a vacuum section formed inthe valve element.
 40. The male medical fluid connector of claim 39wherein the vacuum means comprises a compressible cavity formed in thevacuum section of the valve member, the cavity being compressed when thevalve member is in the open position and the cavity being restored whenthe valve element is in the closed position.
 41. The male medical fluidconnector of claim 40 further comprising a resilient member that biasesthe valve member to the closed position.
 42. The male medical fluidconnector of claim 39 wherein the valve member comprises a dual stagevalve, a first valve stage of which isolates the vacuum means fromupstream liquid before a second valve stage closes.
 43. The male medicalfluid connector of claim 42 wherein the vacuum means is located betweenthe first and second valve stages of the dual stage valve and isconfigured such that after the first valve stage closes, the vacuummeans creates the relative vacuum thereby drawing liquid that may existon the forward end into the forward end of the tubular member before thesecond valve stage closes.
 44. The male medical fluid connector of claim43 wherein the vacuum means comprises a compressible cavity formed inthe valve member, the cavity being compressed when the valve member isin the open position and the cavity being restored when the valveelement is in the closed position.
 45. The male medical fluid connectorof claim 44 further comprising a resilient member that biases the valvemember to the closed position.
 46. A method of disengaging a malemedical fluid connector from a female connector, the male connectorhaving a forward end inserted into the female connector duringengagement, the method comprising drawing liquid located on the forwardend of the male medical fluid connector into the forward end upondisconnection of the male connector from the female connector.
 47. Themethod of claim 46 wherein the step of drawing comprises creating arelative vacuum inside the forward end of the male medical connectorupon disengagement of the male connector from a female connector therebydrawing liquid on the forward end into the forward end.
 48. The methodof claim 47 further comprising the step of isolating an internal portionof the male connector from upstream liquid upon disengagement of themale connector from a female connector prior to creating the relativevacuum.
 49. The method of claim 48 wherein the step of creating arelative vacuum comprises restoring a cavity located within the maleconnector from a compressed configuration to an uncollapsed naturalshape during disengagement.
 50. The method of claim 49 furthercomprising the step of biasing the cavity to the natural shape.
 51. Themethod of claim 48 wherein the step of isolating comprises closing afirst valve internal to the male connector.
 52. The method of claim 56wherein the step of creating a relative vacuum comprises restoring acavity located within the male connector between the first valve and theforward end from a compressed configuration to a natural shape duringdisengagement.
 53. The method of claim 52 further comprising the step ofclosing a second valve located internally at the forward end after thestep of restoring, such that the cavity is located between the first andsecond valves.
 54. The method of claim 46 further comprising the step ofisolating an internal portion of the male connector from upstream liquidupon disengagement of the male connector from a female connector priorto creating the relative vacuum.
 55. The method of claim 54 wherein thestep of drawing comprises creating a relative vacuum inside the forwardend of the male medical connector upon disengagement of the maleconnector from a female connector thereby drawing liquid on the forwardend into the forward end.
 56. The method of claim 55 wherein the step ofisolating comprises closing a first valve internal to the maleconnector.
 57. The method of claim 56 wherein the step of creating arelative vacuum comprises restoring a cavity located within the maleconnector between the first valve and the forward end from a compressedconfiguration to a natural shape during disengagement.
 58. The method ofclaim 57 further comprising the step of closing a second valve locatedinternally at the forward end after the step of restoring, such that thecavity is located between the first and second valves.
 59. The method ofclaim 57 further comprising the step of biasing the cavity to thenatural shape.